Class I U.S. Food and Drug Administration

Glycar SA Pty., Ltd. SJM Pericardial Patch, with EnCap Technology 5x10 cm recall: The impacted lot may not meet the required tensile strength specification

Recall published 11 months ago

The impacted lot may not meet the required tensile strength specification.

The hazard: Device safety concern

The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

What the notice says: The impacted lot may not meet the required tensile strength specification.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-0532-2026
Published
December 3, 2025
Risk level
Class I
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Glycar SA Pty., Ltd.
Product type
Medical devices
Units affected
18 units
Made in
South Africa
Lot / code info
UDI/DI 05414734007269, Lot Number T2506245, exp. 2028.05.25
UPC codes
05414734007269

Products covered by this recall

SJM Pericardial Patch, with EnCap Technology 5x10 cm, Model Number REF C0510; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE

Check your product

The notice names 4 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 05414734007269

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • T2506245

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • 2028.05.25 — 18 units

Model or item number

On the rating label, the box or the instruction sheet.

  • REF C0510

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Glycar SA Pty., Ltd. — The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. If you are a facility, quarantine affected stock and log the correction.
  3. Report device problems to the FDA through MedWatch.
  4. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.

Who pays for a device recall

The manufacturer funds the remedy. The practical question is usually which link in the chain executes it.

  • If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.
  • Ask for written confirmation that the remedy was applied to your serial number. That is what an insurer or a future clinician will want to see.
  • If you bought it yourself online or from a pharmacy, go to the manufacturer’s recall page rather than the retailer; device claims are handled centrally.
  • Where the remedy is a software update, there is nothing to claim, but do confirm the version changed afterwards.

Company contact: Glycar SA Pty., Ltd. — 1 Albert Road, Irene

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Glycar SA Pty., Ltd. medical devices recalled?

The impacted lot may not meet the required tensile strength specification. The impacted lot may not meet the required tensile strength specification.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 05414734007269; lot code T2506245; best-by date 2028.05.25 — 18 units; model number REF C0510. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.

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